Aerie Pharmaceuticals, Inc. and Aerie Distribution, Inc. filed suit on Monday in the District of New Jersey against Micro Labs Limited (MLL) and Micro Labs USA, Inc. over claims that the companies had infringed on Aerie’s patents for Rhopressa and Rocklatan.
The defendants filed two abbreviated new drug applications, or ANDAs, that prompted Aerie’s suit filing. The first ANDA sought approval to produce and market a generic version of the plaintiff’s drug Rhopressa prior to the expiration of the eight patents associated with the drug.
The second ANDA filed by the defendants also sought approval to manufacture and sell a product of the plaintiffs. MLL and ML USA requested FDA approval to manufacture and sell a netarsudil and latanoprost ophthalmic solution, or a generic version of the plaintiff’s product Rocklatan. . The defendants are purportedly are seeking to produce this prior to the expiration of the plaintiff’s ten patents associated with the drug. The defendants contend in their ANDAs that each of the patents-in-suit are invalid, unenforceable, or would not be infringed if the Food and Drug Administration (FDA) approved the defendant’s requests.
Rhopressa is intended to reduce “elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.” Similarly, Rocklatan is intended “for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.”
The plaintiffs maintain that if the FDA approves the ANDAs filed by the defendants, the new generic products that the defendants produce will constitute direct infringement of the patents that the plaintiff holds protecting their products. They assert that the patents-in-suit are both valid and enforceable, the plaintiffs claim.
The complaint cites 18 separate counts of infringement against the defendants. The plaintiff is seeking favorable judgment on all counts, a permanent injunction preventing the defendants from future infringement of the patents, damages and other monetary relief, and any other relief deemed proper by the Court.The plaintiffs are represented by Walsh Pizzi O’Reilly and Falanga, LLP.
